ClinicalTrials.gov record NCT07689604
META 10-19 in Patients With Relapsed/Refractory Autoimmune Hemolytic Anemia
Phase I Clinical Study on the Safety and Tolerability of META 10-19 Infusion in Patients With Relapsed/Refractory Autoimmune Hemolytic Anemia
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This Phase I interventional study evaluates the safety and tolerability of META 10-19, a metabolically armed autologous CD19 CAR T-cell infusion, in people with relapsed or refractory autoimmune hemolytic anemia (AIHA) and Evans syndrome. Participants receive an infusion of their own engineered CAR T cells and are closely monitored; hospitalization for at least 14 days is recommended. The study also collects early data on treatment effects and on how the CAR‑T cells behave in the body.
What it is studying. The study tests the safety and tolerability of META 10-19 (metabolically armed autologous CD19 CAR T cells) in relapsed/refractory AIHA and collects preliminary data on efficacy and pharmacokinetics/pharmacodynamics.
What the researchers hope to learn. Primary goal: evaluate safety and tolerability of META 10-19. Secondary goals: collect preliminary efficacy data (hemoglobin, markers of hemolysis, transfusion needs), measure CAR‑T cell expansion over time (Cmax, Tmax, AUC to Day 28), and assess pharmacodynamic changes in peripheral blood and bone marrow B‑cell and plasma‑cell counts.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
A Study of Metabolically Armed Autologous CD19 CAR T-Cell Therapy (META 10-19) in Patients with Relapsed/Refractory Autoimmune Hemolytic Anemia
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Biological
- Metabolically Armed Autologous CD19 CAR T-Cell therapy
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- Aged 18 to 75 years, regardless of genders.
- Diagnosis of AIHA (including warm antibody type, mixed warm and cold antibody type, cold agglutinin disease) or Evans syndrome, consistent with the Chinese Expert Consensus on the Diagnosis and Treatment of Autoimmune Hemolytic Anemia (2023), or the Diagnosis and Treatment of Autoimmune Hemolytic Anemia in Adults: Recommendations from the First International Consensus Meeting (Blood Rev, 2020), or the Chinese Expert Consensus on the Diagnosis and Treatment of Evans Syndrome (2024 Edition).
- Definition of relapsed/refractory disease, meeting all of the following criteria:
- Hemoglobin < 10 g/dL with clinical manifestations of hemolytic anemia;
- After treatment with at least two immunosuppressive agents (which must include an anti-CD20 monoclonal antibody, with a cumulative dose of the anti-CD20 antibody reaching at least 375 mg/m² × 4, or a total dose of 2.0 g, or at least 6 cumulative administrations with an interval of ≥1 week between each);
- Glucocorticoid therapy for no less than 3 months (except for those with comorbidities that contraindicate corticosteroid use, severe infection, severe osteoporosis, previous fractures, or intolerance to glucocorticoids).
- Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2;
- Estimated life expectancy ≥12 weeks;
- Adequate organ function as assessed by laboratory tests: Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × upper limit of normal (ULN); and minimal pulmonary reserve, defined as dyspnea ≤ grade 1 and oxygen saturation ≥ 93% while breathing room air; creatinine clearance (estimated by Cockcroft-Gault) ≥ 45 mL/min; cardiac ejection fraction ≥ 50%, with no signs of pericardial effusion on echocardiography (ECHO) and no clinically significant electrocardiogram (ECG) abnormalities.
- During the study period (from the signing of this informed consent form until at least 12 months after META 10-19 infusion, and until two consecutive PCR tests show no detectable CAR-T cells in the body), the study participant and their spouse/partner must use appropriate and effective contraceptive measures (excluding rhythm method/calendar-based contraception).
- Study participants must sign a written informed consent form approved by the Ethics Committee prior to the initiation of any screening procedures.
Exclusion criteria
- Previously diagnosed definite lymphoproliferative neoplasms; other malignant tumors within the past 5 years (excluding cured basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, breast carcinoma in situ, and cervical carcinoma in situ).
- Secondary AIHA caused by drugs or infection.
- Presence of active hepatitis or a history of severe liver disease or condition during the screening period:
- Hepatitis B: HBsAg or HBeAg positive; or hepatitis B e antibody (HBe-Ab) and/or hepatitis B core antibody (HBc-Ab) positive with HBV-DNA copy number above the lower limit of detection.
- Hepatitis C: Anti-HCV positive and HCV RNA ≥ lower limit of quantification (LLoQ).
- Human immunodeficiency virus (HIV) antibody positive.
- Active syphilis infection (excluding those with only positive syphilis-specific antibodies).
- Previous history of organ transplantation or hematopoietic stem cell transplantation.
- Severe cardiovascular diseases:
- Cardiovascular disease with New York Heart Association (NYHA) class > 2 within 6 months prior to the first study drug administration.
- Unstable angina or severe arrhythmia requiring medication, including QTcF > 480 ms (calculated by Fridericia's formula).
- Other significant electrocardiogram (ECG) abnormalities, including second-degree type II atrioventricular block, third-degree atrioventricular block, bradycardia (ventricular rate < 50 bpm with clinical symptoms), etc.
- Myocardial infarction within the past 6 months.
- Other cardiac diseases considered unsuitable for enrollment by the investigator.
- Undergone major surgery within the past 4 weeks that is deemed by the investigator as unsuitable for enrollment.
- Presence of active infection (e.g., sepsis, bacteremia, fungemia, uncontrolled pulmonary infection, active tuberculosis, etc.); active infection requiring intravenous anti-infective therapy within 7 days prior to screening.
- Receipt of CAR T-cell therapy within 6 months prior to screening, or positivity for ADA, or positivity for HAMA, or receipt of in vivo CAR T-cell therapy within the previous 6 months; or a history of severe immediate hypersensitivity reaction to any cellular product, excipients, or related drugs used in this study.
- Individuals with a history of epilepsy or other active central nervous system diseases (including but not limited to cerebrovascular accident, cerebral hemorrhage, cerebral infarction, severe traumatic brain injury, dementia, organic brain syndrome, etc.).
- Women with a positive pregnancy test or who are breastfeeding; women of childbearing potential and all male study participants who are unwilling or unable to use effective contraceptive methods during the study period and for at least 12 months after study drug infusion.
- Any other condition or circumstance that, in the investigator's opinion, would make the participant unsuitable for participation in this study.
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Detailed description from the registry
This is a Phase I clinical study evaluating metabolically armed autologous CD19 CAR T-cell therapy (META 10-19) in patients with relapsed/refractory autoimmune hemolytic anemia (AIHA). The main purpose of this study is to assess the safety and tolerability of this therapy in patients with relapsed/refractory AIHA. -Primary Objective: To evaluate the safety and tolerability of metabolically armed autologous CD19 CAR T-cell therapy (META 10-19) in patients with relapsed/refractory autoimmune hemolytic anemia (AIHA). -Secondary Objectives:
- To evaluate the preliminary efficacy of metabolically armed autologous CD19 CAR T-cell therapy (META 10-19) in study participants with relapsed/refractory AIHA.
- To assess the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of the metabolically armed autologous CD19 CAR T-cell therapy (META 10-19).
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participants will receive an intravenous infusion of META 10-19 CAR T-cells, be closely monitored (at least 24 hours) and are generally recommended to stay in hospital for a minimum of 14 days (length determined by the investigator). Follow-up visits include safety and laboratory assessments on Day 28 and at Months 2, 3, and 6; blood tests will measure CAR‑T cell levels and B‑cell counts, and bone‑marrow sampling may be performed to assess pharmacodynamic effects. Safety (adverse events) is monitored especially during the first 28 days, and PCR testing for CAR‑T cells will be done until two consecutive negative tests. Participants must agree to the study's contraception requirements (during the study and for at least 12 months after infusion).
How the study is structured. Phase I, single-group (all participants receive the investigational treatment), open-label interventional study. Participants receive an intravenous infusion of META 10-19 and are observed closely for adverse events and laboratory measures over follow-up visits; there is no masking or control group.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an early-phase study, mainly about safety and dose. What is already known about this treatment?
- The registry says recruitment has not started. When is it expected to open, and can I register interest now?
- The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on autoimmune hemolytic anemia
Important dates
- Study start
- Sep 20, 2026 (estimated)
- Primary completion
- May 1, 2027 (estimated)
- Study completion
- Oct 1, 2028 (estimated)
- Target enrollment
- 18 participants (estimated)
- Last updated on registry
- Sep 21, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, China
- Principal investigator
- Jun Shi, Director of the Red Blood Cell Diseases Center & Director of the Regenerative Medicine Clinic
Institute of Hematology & Blood Diseases Hospital, China - Collaborators
- Hangzhou Leman Biotech Co., Ltd
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- RuoNan Li 📞 86+18810169952 ✉ liruonan@ihcams.ac.cn
Participating sites (1)
- Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, 300000 · China
- RuoNan Li · 86+18810169952 · liruonan@ihcams.ac.cn
- Jun Shi
- Ruonan Li
Terms used on this page · explanations by MedicalUpdates.ai
- CAR T
- A treatment in which a person's own immune cells (T cells) are collected, modified in a laboratory to recognise a target, and returned to the body.
- Relapsed/Refractory
- A condition that has not responded to a treatment. 'Relapsed' means it responded and then came back; 'refractory' means it did not respond in the first place.
- immunosuppressive
- A medicine that reduces the activity of the immune system. Studies of autoimmune conditions often require a stable dose, a prior failure, or a washout of such medicines.
- Glucocorticoid
- Steroid medicines, such as prednisone, that reduce inflammation. Studies often require a stable dose at entry or measure whether the study treatment allows the dose to be reduced.
- ECOG
- A scale from 0 to 5 that describes how a person's condition affects daily activity. 0 means fully active; 1 means restricted in strenuous activity; 2 means able to self-care but unable to work; higher numbers mean more limitation.
- life expectancy
- Some studies require that, in the investigator's judgement, a participant is likely to live long enough to complete the study period. It is a study requirement, not a prediction about any individual.
- upper limit of normal
- The highest value of a blood test that a laboratory considers normal. Criteria such as '≤ 3 × ULN' mean the result must be no more than three times that value.
- creatinine clearance
- A measure of kidney function, calculated from a blood creatinine level together with age, weight and sex.
- echocardiography
- An ultrasound scan of the heart. A transesophageal echocardiogram is done through a probe passed into the food pipe for a closer view.
- electrocardiogram
- A recording of the heart's electrical activity. QTc is one measurement from it; some drugs are avoided if it is prolonged.
- informed consent form
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- screening period
- The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
- study drug
- A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.
- enrollment
- The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
- women of childbearing potential
- Studies often ask participants who could become pregnant, or could father a child, to use contraception during the study and for a period afterwards, because the effect of the treatment on a pregnancy is unknown.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
- Phase I
- An early-stage study, usually small, mainly to check safety, side effects and how much of a treatment can be given. Whether it works is not the main question yet.
- Primary Objective
- The main result the study is designed to measure and report on. Other results, called secondary outcomes, are also collected.
- pharmacokinetic
- How the body absorbs, distributes, breaks down and removes a drug. It is studied by measuring drug levels or related substances at set times after a dose.
- pharmacodynamic
- What a drug does to the body, for example how it changes a blood marker or a symptom, and how that relates to the dose.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this website; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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